Celcuity's Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort
Celcuity announced that the Phase 3 VIKTORIA-1 trial met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival for the gedatolisib triplet regimen in PIK3CA mutant HR+/HER2- advanced breast cancer. The company plans to submit a supplemental New Drug Application to the FDA based on these positive topline results, while a separate NDA for the PIK3CA wild-type cohort already has a PDUFA goal date of July 17, 2026.
Key figures
- Drug Name
- gedatolisib
- Phase Of Trial
- Phase 3
- Pdufa date
- July 17, 2026
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